510(k) K060537
- Device
- EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120
- Applicant
- ENGINIVITY LLC
- 510(k) number
- K060537
- Product code
- LGZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-08
- Date received
- 2006-02-28
- Regulation
- 880.5725
- Classification name
- Warmer, Thermal, Infusion Fluid
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- PENELOPE GRECO
- Address
- 8 Gray Lodge Rd. Kittery ME US 03904 03904
FDA Registration Numbers#
- 3030125051
- 1058584
- 3013557562
- 3005813632
- 1219702
- 1125615
- 3003771969
- 9616074
- 9617473
- 3010317211
- 3010876604
- 3021073836
- 3036108847
- 1419937
- 9681599
- 2427500
- 9617604
- 3006342679
- 2031963
- 1649518
- 3009746061
- 3005382983
- 3006946102
- 3004167615
- 3008258694
- 1043572
- 3012307300
- 3031841433
- 9614609
- 1033902
- 2528981
- 3006158088
- 2024242
- 3005730406
- 3010432890
- 3004986960
- 3004491421
- 3007495879
- 1314417
- 2244478
- 1220477
- 1000312731
- 3012302888
- 2032112
- 2246552
- 1643817
- 1054811
- 3032580628
- 3005941719
- 3007127244
- 3003144120
- 3012494290
- 3013429468
- 3003464075
- 3010663836
- 2032098
- 2936485
- 9616567
- 1650754
- 3006405073
- 3003018722
- 3038241934
- 3008388260
- 3008959444
- 3003793891
- 3003018304
- 3008773490
- 3020978007
- 2183744
- 3042272797
- 1825014
Source Documents#
Other 510(k) Records For Product Code LGZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260988 | °M Warmer System with °M Station | Mequ A/S | 2026-04-24 |
| K252636 | Fluido Compact System | The Surgical Company International B.V. | 2025-11-18 |
| K251733 | Fluido® AirGuard System | The Surgical Company International BV (As Tsc Life) | 2025-09-04 |
| K232107 | °M Warmer System | Mequ A/S | 2024-05-31 |
| K211618 | Fluido Compact Blood and Fluid Warming System | The Surgical Company International B.V. | 2023-06-05 |
| K211800 | Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2022-12-08 |
| K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | Smisson-Cartledge Biomedical, LLC | 2022-08-12 |
| K213191 | S-Line | Barkey GmbH & Co. KG | 2022-05-24 |
| K192325 | Quantum Blood and Fluid Warming System | Life Warmer, Inc. | 2019-10-18 |
| K180842 | MAC Medical D-Series Blanket and Solution Warming Cabinets | Mac Medical, Inc. | 2019-03-05 |
| K181775 | Quantum Blood and IV Fluid Infusion Warmer | Life Warmer, Inc. | 2019-01-28 |
| K180154 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2018-04-27 |
| K171215 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-09-27 |
| K163708 | QiF Blood and Fluid Warmer | Quality IN Flow , Ltd. | 2017-04-20 |
| K161613 | Hang&Go PAC | Rand S.R.L. | 2016-12-28 |
Legacy Summary#
summary
FDA Review#
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